Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm Positive Control 100, Elia Anca/Gbm Po
FDA 510(k) K140225 · Phadia US, Inc.
510(k) numberK140225
Submission
- Device name
- Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm Positive Control 100, Elia Anca/Gbm Po
- Applicant
- Phadia US, Inc.
Freiburg Im Breisgau, DE - Received
- January 29, 2014
- Decision date
- October 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | Zeus Scientific | 08/21/2026SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | Zeus Scientific | 05/07/2025SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | Euroimmun Us, Inc. | 05/24/2018SE |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | Aesku.Diagnostics GmbH & Co. KG | 03/23/2018SE |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB · Traditional | Phadia AB | 03/13/2018SE |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional | Inova Diagnostics, Inc. | 02/03/2017SE |
| K112545 | Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional | Inova Diagnostics, Inc. | 07/31/2012SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | Biomedical Diagnostics (Bmd) SA | 11/03/2010SE |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
| K092600 | Immulisa PR3 Antibody ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
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|---|---|---|
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| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | 12/23/2013SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | 08/28/2013SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | 09/13/2012SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | 06/22/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | 12/22/2011SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | 09/30/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | 08/13/2010SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | 06/07/2010SE |
Questions and answers
When was Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm Positive Control 100, Elia Anca/Gbm Po cleared by the FDA?
Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm Positive Control 100, Elia Anca/Gbm Po (K140225) received a 510(k) decision of Substantially Equivalent on October 27, 2014, 271 days after the submission was received.
What is the product code of K140225?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.